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Number: 201102254 Principal Investigator: Edmundowicz, Steven
Title: Endoscopic Resection or Ablation for Patients with Dysplasia or Intramucosal Cancer Requiring Treatment of Barrett’s Esophagus: the ERADICATE trial A Multi-Center Randomized Controlled Trial
Phase: II Disease Site: Esophagus
Participating Site(s):
 
Main Campus
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Contact: 800-600-3606 or info@ccadmin.wustl.edu

Description:
This is a multi-center prospective, RCT conducted at 4 centers. 82 patients with HGD and/or EC who meet the study criteria will be enrolled, undergo a baseline diagnostic EMR and then be randomized in a 1:1 ratio to undergo treatment by either stepwise endoscopic mucosal resection (S-EMR) or radiofrequency ablation (RFA). The initial staging EMR will not extend more than 50% of the esophageal circumference or more than 2 cm in longitudinal extent. Patients in the S-EMR group will undergo step-wise eradication of the BE segment using the Duette multi-band mucosectomy kit (Cook Medical, FDA approved) whereas those in the RFA group will undergo BE ablation using the endoscopically-guided HALO radiofrequency ablation system (Barrx Medical, FDA approved).
 
More Information:
Internal Protocol Documents (requires Siteman administrative database password)